PDS

Contents

Introduction
Definitions
1) Performance

1.0 Function
2.0 Appearance
3.0 Reliability
4.0 Environment
5.0 Ergonomics
6.0 Quality
7.0 Weight

2) Operation Requirements

8.0 Use
9.0 Maintenance
10.0 Safety

3) Manufacture Requirements
11.0 Process
12.0 Materials
13.0 Assembly
14.0 Packing
15.0 Quality

4)

Standards

Introduction
The PDS is being created so we can see in detail what the product
has to do, more detail included means a more successful product. It
also allows designers to see the customer needs more clearly and
design around these specifications. My product will be an easier
alternative product to test blood sugar for diabetics. The aim is to
create something that will be less time consuming and easier to test
when on the go, e.g. flat surface wont be required like most other
blood meters. It is also important the product interacts well with the
user and it is something the enjoy carrying around, making it harder
to forget an important piece of medical equipment.

Definitions

MMOL/L MILLIMOLES/LITRE
mmol/l
mg/dl
interpretation
----------------------2.0
35
extremely low, danger of unconsciousness
3.0
55
low, marginal insulin reaction
4.0
75
slightly low, first symptoms of lethargy etc.
5.5
100
mecca
5-6
90-110 normal pre-prandial in nondiabetics
8.0
150
normal postprandial in nondiabetics
10.0
180
maximum postprandial in nondiabetics
11.0
200
15.0
270
a little high to very high depending on patient
16.5
300
20.0
360
getting up there
22
400
max mg/dl for some meters and strips
33
600
high danger of severe electrolyte imbalance

1) Performance
requirements
1.0 Function

1.1 Product must be able to allow user to test blood glucose, or show how it would work

1.2 Must allow blood testing be less time consuming than existing products

2.0 Appearance

2.1 It must be discreet so it wont draw attention from others (doesnt look medical)

2.2 It will be aesthetically pleasing so user enjoys wearing it (looks like a normal wrist watch)

3.0 Reliability

3.1 Must be powered by a strong battery as it will be in constant use(1.5 V, type AAA, LR03, AM 4 or Micro)

3.2 Battery life: Approximately 500 tests or approximately 1 year

3.3 Must last several years with constant use

4.0 Environment

4.1 Must operate accurately when in temperatures -10 to 70 degrees

4.2 Must remain comfortable on the wrist after several hours of use

5.0 Ergonomics

5.1 Must be adjustable to fit on a wide range of different sizes of wrists

5.2 Must be easy to operate and understand, so it interacts well with the user

5.3 Must appeal to a wide range of users so it can be available to every diabetic, so it is a product they
enjoy wearing and it wont feel like as much of a chore to test blood if they enjoy the product. Must be no
bigger than 75 x 50 x 30 mm L W H

5.4 Must be comfortable at all times.

5.5 Strap must be adjustable between 152.4mm(6inches) and 203.2mm (8inches)

Performance requirements
6.0 Quality

Must function properly, I.e. be a high quality product that allows extremely accurate testing.

Must help the user maintain blood glucose between 5.0 mmol/l to 9.9 mmol/l

7.0 Weight

Weight must not exceed 100g

Must be light enough to still be comfortable after frequent use
Must not strain the user in anyway by being too heavy.

Manufacturing
8.0 Process
8.1 The product would be injection moulded if it was being mass produced.
8.2 A moulding press is loaded within the mould cavities, and a pellet of encapsulating material
8.3 Encapsulation of the integrated circuits (of the glucose detector) is achieved by heating the encapsulating material pellet and pressing it
within the chamber using a transfer plunger, which causes the pellet to liquefy and flow into the mould cavities through small passages
between the chamber and the mold cavities.
8.4 After allowing the encapsulating material to solidify again, the moulding press is opened and the mould parts are separated.
8.5 After removal of the encapsulated integrated circuits, the open moulding press is ready to receive new inserts and encapsulating material
pellet to repeat the encapsulating process.
9.0 Materials
9.1 Thermoplastic resins would be used in the injection moulding such as phenol resin, epoxy resin, silicone resin, unsaturated polyester resin,
and other thermosetting resins.
9.2 The meter itself is composed of a plastic case that houses the printed circuit board and sensors. There is a liquid crystal display (LCD) that
will show the readings of the blood glucose.
10.0 Assembly
10.1 Two plastic casings would be made, the circuit board and other components placed, and the casings would be glued together.
10.2 Product must be easy to assemble, all components must fit together and function
10.3 Must take no longer than 9-10 weeks to manufacture prototype
10.4 Must be easy to operate
10.5 Prototype will use some existing components (such as the cassette which carries sample and is changed after 50 tests)
10.6 Product will include backup finger pricker in case it is forgotten
10.7 Cassette and finger pricker should connect together and work efficiently
10.8 Must display blood glucose in mmol/l
10.9 Allow the cleaning of the cassette to be easy.
11.0 Packing
11.1Packaging and transport costs kept to a minimum, preferably 5% of the unit cost
12.0 Quality
12.1 Product should not fail within a year
12.2 Product life span should last up to at least 3 years and have no major issues within that time.

Operation Requirements
13.0 Use

13.1 The product will be a wrist watch blood glucose meter

13.2 The product will be a new product that allows diabetics to test blood sugar more easily.

13.3 The product will be discreet, meaning it doesnt look medical and wont draw attention
from others.

13.4 The whole blood test process should take less than 10 seconds

13.5 Will be worn on the wrist, and looks like a watch

13.6 2000 test memory plus 7, 14, 30 and 90 day averages

14.0 Maintenance

14.1 Should be maintenance free apart from battery change and disposing of cassettes.

14.2 No special tools should be required for maintenance.

15.0 Safety

15.1 Electric circuit must not fail and cause danger to the user

15.2 Must perform well.

Standards

16.0 BS British Standards

16.1 BS 7671 Requirements for electrical installations

National standards international

ISO International Standard Organisation

EN European Standards

UL Underwriters laboratories inc (product safety testing)

CE Certificate European